Dr Heike Specht
Binger Strasse 173
For medical media, outside the US only
Ingelheim, Germany, 19 May 2010, 08:00 CET – Significantly more pre-menopausal women with hypoactive sexual desire disorder (HSDD) reported a clinically meaningful improvement in their condition with flibanserin 100mg compared with placebo, according to new research announced today.1 Flibanserin is an investigational, non-hormonal treatment being developed by Boehringer Ingelheim for pre-menopausal women with HSDD.
More than 1,300 women were included in the pre-specified, pooled Phase III study analysis, presented at The American Congress of Obstetricians and Gynaecologists (ACOG) annual clinical meeting. All of the women had HSDD – a medical condition characterised by a decrease in sexual desire associated with marked distress and/or interpersonal difficulties.2
“We know that flibanserin is effective and well tolerated in a clinical setting, but it’s important to understand too whether patients themselves see a benefit from treatment,” said John Thorp, study investigator and Professor of Obstetrics and Gynaecology at the University of North Carolina Medical School. “These study results are very encouraging – not only did women report an improvement in their HSDD symptoms, but they felt the improvement was meaningful to them and their overall well-being.”
The patients’ perspective analysis builds on existing Phase III clinical trial data which demonstrate that flibanserin 100mg taken once daily at bedtime significantly increased sexual desire while significantly decreasing the distress associated with HSDD.3 This was reflected in a significant increase in the number of Satisfying Sexual Events (SSEs)
Study participants evaluated their treatment based on two measures – overall improvement in their condition, and the question “Do you believe you experienced a meaningful benefit from the study medication?”
Of 1,338 participants questioned (flibanserin=659, placebo=679):
Of 1,219 participants questioned (flibanserin=593, placebo=626):
A second pre-specified analysis of the phase III study data presented at the meeting looked specifically at women who completed treatment to trial end.
Those who received flibanserin 100mg vs. placebo experienced statistically significantly:*
“Although HSDD affects thousands of women, it is often misunderstood or overlooked,” said Paula Hall, a sexual and relationship psychotherapist from the UK. “In both of these study analyses, we’re seeing very positive outcomes with flibanserin, which is really quite exciting and could hold hope for those suffering with this distressing condition.”
About the studies
In both studies, data from two 24-week randomised, placebo-controlled Phase III North American trials (VIOLET® and DAISY®) were pooled in a pre-specified analysis.
1. Patient perspectives on flibanserin treatment1
In the first analysis, study participants were asked to:
2. Analysis of women who completed treatment to study end4
The second analysis specifically evaluated those women who completed 24 weeks’ treatment (n=971, 70.5%). Co-primary endpoints were change from baseline to study end in the number of satisfying sexual events (SSE) and sexual desire score measured using a daily electronic diary (eDiary).
Secondary endpoints included change in Female Sexual Function Index (FSFI) desire domain, FSFI total, Female Sexual Distress Scale-Revised (FSDS-R) Item 13 and FSDS-R total scores.
The majority of these tools have been independently developed. All measures have undergone rigorous testing to ensure they are valid and reliable.
Boehringer Ingelheim is investigating flibanserin as a novel, non-hormonal treatment for premenopausal women with HSDD. Flibanserin 100mg, taken once daily orally has been proven effective and well-tolerated in phase III clinical trials in these women suffering from HSDD.3 The intended brand name for flibanserin is Girosa®.
How does flibanserin work?
Flibanserin is a 5-HT1A agonist and 5-HT2A antagonist. The term refers to the fact that flibanserin mainly targets these two types of serotonin receptors, the 5-HT1A receptor as an agonist and the 5-HT2A receptor as an antagonist. Preclinical evidence shows that flibanserin targets these receptors preferentially in selective brain areas. An intricate interplay between stimulatory neurotransmitter systems (dopamine and norepinephrine) and inhibitory systems (serotonin, 5-HT) is part of the natural sexual response. By modulating these neurotransmitter systems in selective brain areas, flibanserin may correct an imbalance in these systems, which leads to a healthy sexual response.5
About Hypoactive Sexual Desire Disorder
HSDD is a form of Female Sexual Dysfunction (FSD). As defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV), HSDD is the persistent lack (or absence) of sexual fantasies or desire for any form of sexual activity marked by distress or interpersonal difficulty and not better accounted for by another disorder (except another sexual dysfunction), direct physiological effects of a substance (including medications) or a general medical condition. Generalised, acquired HSDD is not limited to certain types of stimulation, situations or partners, and develops only after a period of normal functioning.2 Low sexual desire with associated distress is the most commonly reported female sexual complaint. In prevalence studies6 approximately 1 in 10 women reported low sexual desire with associated distress, which may be HSDD. Sexual Desire Disorders are generally under-diagnosed and there are currently no pharmacological treatments available for pre-menopausal women with HSDD. HSDD has been recognised as a medical condition for over 30 years.
Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the USA.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21% of net sales in its largest business segment Prescription Medicines on research and development.
1Jolly E, Thorp JM, Clayton AH, et al. Patients’ perspective of efficacy of flibanserin in pre-menopausal women with HSDD. Oral presentation at the 58th Annual Clinical Meeting of the American Congress of Obstetricians and Gynaecologists (ACOG), May 2010.
2Sexual and gender identity disorders. In: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Association; 2000:493-538.
3Jolly E, Clayton AH, Thorp J, et al. Efficacy of flibanserin 100 mg qhs as a potential treatment for Hypoactive Sexual Desire Disorder in pre-menopausal women. Oral presentation at the European Society of Sexual Medicine Congress, November 2009.
4Thorp JM, Clayton AH, Jolly E, et al. Efficacy of flibanserin in premonopausal women with HSDD who completed 24 weeks’ treatment. Oral presentation at the 58th Annual Clinical Meeting of the American College of Obstetricians and Gynaecologists (ACOG), May 2010.
5Allers K, Dremencov E, Ceci A, et al. Acute and repeated flibanserin administration in female rats modulates monoamines differentially across brain areas: a microdialysis study. J Sexual Med 2010:7(5):1757-1767.
6Shifren JL, Monz, B, Russo P, et al. Sexual Problems and Distress in United States Women: Prevalence and Correlates. Obstet Gynecol 2008;112(5): 968-969.
* see notes to the editors for an explanation of study measures